Performance of Two Silicone Hydrogel Toric Contact Lenses

Not Applicable

Completed

Brief Summary: Evaluation of the clinical performance of two toric contact lenses in a 2-week, single masked (subject), daily wear, randomized, bilateral, parallel group study.

Recruitment & Eligibility

Inclusion Criteria

Be between 18 and 45 years of age.
Sign Written Informed Consent (See separate document).
Be an existing successful daily wear toric soft contact lens.
Require a visual correction in both eyes (monovision or uniocular fitting is NOT allowed).
Does not require presbyopic correction (can read J1 @ normal reading distance).
Have a sphere requirement in the range -1.00 and -5.00D (-5.25D refractive)
Have refractive astigmatism between 0.75D and 2.50D in both eyes.
Achieve visual acuity of 20/30 or better in each eye with spherical distance correction.
Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
- No amblyopia.
- No evidence of lid abnormality or infection.
- No conjunctival abnormality or infection.
- No clinically significant slit lamp findings (i.e. stromal edema, vascularisation, infiltrates or abnormal opacities).
- No other active ocular disease.

Exclusion Criteria

Requires concurrent ocular medication.
Clinically significant (Grade 3 or 4) corneal stromal haze, corneal vascularisation, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
Corneal staining Grade 3 in more than one region.
Has had refractive surgery. Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
Abnormal lacrimal secretions.
Pre-existing ocular irritation that would preclude contact lens fitting.
Keratoconus or other corneal irregularity.
Polymethyl methacrylate (PMMA) or Rigid Gas Permeable (RGP) lens wear in the previous 8 weeks
Extended lens wear in last 3 months.
Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.
Diabetic.
Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
Pregnancy, lactating or planning a pregnancy at the time of enrolment.
Participation in any concurrent clinical trial or in last 60 days.

Arm && Interventions

Group	Intervention	Description
balafilcon A toric	balafilcon A toric	balafilcon A, daily wear, toric contact lens worn for two weeks
senofilcon A toric	senofilcon A toric	senofilcon A, daily wear, toric contact lens worn for two weeks

Primary Outcome Measures

Name	Time	Method
Lens Orientation	1 minute after insertion	Proportion of eyes with lens orientation within 5 degrees of optimal
Lens Stability	10-15 minutes after insertion	Lens stability is measured as the amount of rotation induced from blink after the lens has settled.
Subjective Comfort	2 weeks of lens wear	Subjective comfort was derived from a weighted combined score calculated from individual comfort-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response. \>0 = comfortable, \< 0 = uncomfortable. Combined measures from Week 1 and Week 5.

Secondary Outcome Measures

Name	Time	Method
Time to Fit Lens	after lens insertion	Time required for the optometrist to fit the lens.
Subjective Lens Vision	measured at 1 and 2 weeks	A weighted combined score calculated from individual vision-related questions asked on a 1-5 scale: 1 = most negative response to 5 = most positive response was used to derive vision outcomes. \>0 = satisfactory vision, \< 0 = unsatisfactory vision. Analysis is performed on combined 1 week and 2 week data.
Overall Corneal Staining	After 2 weeks use	National Eye Institute 0-3 Scale: Grade 0 = Normal, Grade 1 = Mild, superficial stippling, Grade 2 = Moderate, punctuate staining including superficial abrasion of the cornea, Grade 3 = Severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.

Locations (19): Matus Eyecare
🇺🇸
Franklin, Wisconsin, United States
Dr. Larry Menning
🇺🇸
Chamberlain, South Dakota, United States
Camp Eye Care Clinic
🇺🇸
North Little Rock, Arkansas, United States
James R. Dugue, O.D.
🇺🇸
Mission Viejo, California, United States
Executive Park Eye Care
🇺🇸
Colorado Springs, Colorado, United States
Dr. Ted Brink and Associates
🇺🇸
Jacksonville, Florida, United States
Grene Vision Group
🇺🇸
Neodesha, Kansas, United States
Advanced Eyecare, PC
🇺🇸
Raytown, Missouri, United States
Dr. James Brobst
🇺🇸
Florence, New Jersey, United States
Fine Eye Care Associates
🇺🇸
Rochester, New York, United States
Selden Eyecare LLC
🇺🇸
Kittanning, Pennsylvania, United States
Warren Ophthalmology Associates
🇺🇸
Warren, Ohio, United States
Dr. David W. Ferris and Associates
🇺🇸
Warwick, Rhode Island, United States
Nittany Eye Associates
🇺🇸
State College, Pennsylvania, United States
Wishnow-Sugar Vision Group
🇺🇸
Katy, Texas, United States
Dr. William Bogus
🇺🇸
Salt Lake City, Utah, United States
Midlothian Optometric Center
🇺🇸
Midlothian, Virginia, United States
The Eye Specialists, Ltd.
🇺🇸
Virginia Beach, Virginia, United States
The Eye & Contact Lens Clinic
🇺🇸
Bremerton, Washington, United States